Study Finds Heart Stents May Be Overused

A new study has found that heart stents may be overused in the United States, specifically on patients diagnosed with stable heart disease.

A review of eight large clinical trials revealed that opening narrowed arteries with stents did not provided added benefits, versus aggressive medicine-based therapy alone, as a first-line treatment option for patients with stable heart disease, said WebMD. Stents prop open unhealthy arteries during angioplasty to enable blood vessels to remain unblocked. Nonsurgical angioplasty utilizes a small balloon to unblock arteries.

When compared to medication alone, stenting with medication failed to result in reduced deaths, nonfatal heart attacks, emergency bypass procedures, chest pain, and other symptoms in four years of follow-up, said WebMD. David L. Brown, MD, of Stony Brook University Medical Center in New York, one of the study’s researchers, argued that there are too many stent procedures performed in the U.S. annually on patients not first offered medication to manage their risk factors for heart attack and stroke.

“In our analysis, a-third of patients ended up needing stents because medical management was not effective for relieving symptoms, but two-thirds did not need them,” Brown told WebMD. Although there are known benefits to opening newly blocked arteries during heart attack, many studies have found little benefit for performing angioplasty with or without stents when not in an emergency situation, said WebMD.

Over 400,000 nonemergency coronary stenting procedures are performed annually in the U.S., said the American Heart Association (AHA). Should two-thirds be avoided, there would be a huge correlative savings in health dollars, noted Brown. One estimate found that a reduction of elective stent procedures by just one-third would provide $6 – $8 billion in annual savings to the U.S. health system, said WebMD.

The AHA and the American College of Cardiology (ACC) recommend aggressive medication treatment as the initial therapy for stable angina, also known as heart-related chest pain with exertion, or asymptomatic narrowed arteries, WebMD explained. A recent study revealed that over half of these patients underwent angioplasty and stent implantation before drug treatment. The new analysis appears in the journal Archives of Internal Medicine and involved a review of 7,229 patients treated for stable heart disease between 1997 and 2005, said WebMD. About half received medicated stents; the remainder received medication alone.

The study said up to 76% of stable heart disease patients who are first treated with medications, could avoid angioplasty and stenting, leading to savings of about $9,500 per patient, said WebMD. “As more and more studies show that medicine works well and is cheaper and less risky than these interventions, I think practitioners—even interventional cardiologists—will be adopting this strategy more and more,” AHA President Gordon Tomaselli, MD, told WebMD. Tomaselli also directs the cardiology division at Johns Hopkins University School of Medicine.

We recently wrote that the U.S. Food & Drug Administration (FDA) required a warning on the new Boston Scientific heart stent as it continues to investigate a rare and serious health issue with the Promus Element. The FDA mandated Boston Scientific warn physicians about the issue when the device was approved in November, despite reports of rare device deforming following implantation (longitudinal stent deformation), which occurs in stents made by Medtronic Inc. and Abbott Laboratories Inc, but tends to occur most frequently with the Promus Element, said the FDA. The risks, though rare, are potentially significant; however, because benefits outweigh potential risks, the agency approved the Promus Element Plus drug-eluting heart stent. Of note, Boston Scientifics’ request for pre-market approval came seven months sooner than expected.